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Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers

2018年7月26日 更新者：John P. Richie、Milton S. Hershey Medical Center

Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers

The overall objectives of this clinical study are to determine in smokers the short term effects of switching to tobacco products that deliver low levels of nicotine or reactive oxygen/nitrogen species (ROS/RNS) on smoking behavior and biomarkers of tobacco smoke exposure and oxidative stress.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65 who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol, Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L&M Menthol, Pyramid Red, Newport Red, Newport Menthol.

If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.

Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.

Study overview:

Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day

Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day

Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day

Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form

For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392

*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA

研究类型

介入性

注册 (实际的)

37

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • Penn State Hershey

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 21-65
  • Smoke 10 cigarettes/day or more for at least one year
  • Read and write in English
  • Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes
  • Able to understand and provide consent to study procedures
  • Plan to live in the local area for the next month
  • Women not pregnant or nursing and taking steps to avoid pregnancy
  • No quit attempt in the last one months and not planning to quit in the next month

Exclusion Criteria:

  • Currently pregnant or nursing
  • Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data
  • Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana)
  • Currently reducing or planning to reduce cigarette consumption in the next month
  • Use of smoking cessation medicine in the past 3 months
  • History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
  • Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate)
  • Significant medical condition, i.e. stroke, MI, cancer, in the last month
  • Currently using illegal drugs

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Reduced Nicotine Cigarettes
Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.
其他：Reduced Nicotine Cigarettes
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
其他名称：
  • Cigarette contains .28mg (.29mg/menthol) of nicotine
实验性的：Reduced ROS/RNS
Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.
其他：Reduced ROS/RNS
Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
其他名称：
  • Cigarette to be determined by lab experiment
安慰剂比较：Control Group
Participants will be assigned to continue smoking their usual brand of cigarettes.
其他：Control
Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Smoking Topography
大体时间：8 days
measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.
8 days

次要结果测量

结果测量
措施说明
大体时间
Biomarkers of oxidative stress
大体时间：4 times over the 22 day study period
biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG).
4 times over the 22 day study period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Milton S. Hershey Medical Center

合作者

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Food and Drug Administration (FDA)

调查人员

  • 首席研究员：John Richie, Ph.D、Milton S. Hershey Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年1月1日

初级完成 (实际的)

2017年1月1日

研究完成 (实际的)

2017年1月1日

研究注册日期

首次提交

2015年4月9日

首先提交符合 QC 标准的

2015年4月9日

首次发布 (估计)

2015年4月14日

研究记录更新

最后更新发布 (实际的)

2018年7月27日

上次提交的符合 QC 标准的更新

2018年7月26日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • STUDY00001996
  • 5P50DA036107-02 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

At this time we have no plan for sharing, however if need should arise, then sharing may be a possibility.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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